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FDA Flags Novo Nordisk Over Misleading Wegovy TV Spot

[ Price : $8.95]

FDA tells Novo Nordisk that a new direct-to-consumer television ad for the newly launched Wegovy (semaglutide) oral weight-loss pi...

Regenxbio Gets Complete Response for Gene Therapy

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FDA issues Regenxbio a complete response letter on its BLA seeking accelerated approval for RGX-121 (clemidsogene lanparvovec), a ...

Compounding Group Questions Thyroid Extract Classification

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The Alliance for Pharmacy Compounding petitions FDA asking that it reverse its classification of desiccated thyroid extract as a b...

FDA Clears Medians AI Lung Cancer Screener

[ Price : $8.95]

FDA clears a Median Technologies 510(k) for eyonis LCS, the first artificial intelligencebased device cleared for both detection a...

Partial Agreement in PDUFA Talks on Regulatory Science

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FDA drug regulators and pharmaceutical industry representatives reach a partial agreement on drug development tools, including bio...

BIO Urges Broader Guidance on Monoclonal Antibody Safety Testing

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The Biotechnology Innovation Organization urges FDA to broaden application of its draft guidance on Monoclonal Antibodies: Streaml...

Hims & Hers Scraps Compounded GLP-1 Pill Program

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Faced with increasing FDA scrutiny and litigation threats from Novo Nordisk, Hims & Hers abruptly shelves its GLP 1 weight loss pi...

FDA Removes Use Limitation for Yescarta in Rare Lymphoma

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FDA approves a Kite Oncology labeling update for CAR-T therapy Yescarta (axicabtagene ciloleucel), removing a previous limitation ...

Makary Warns Illegal Copycat Drugs Will Face Swift Enforcement

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FDA pledges to move quickly against companies that mass-market illegal copycat drugs by portraying them as equivalent to agency-ap...

Breakthrough Status for Sonorous BosSTENT for Pulsatile Tinnitus

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FDA grants Sonorous Neurovascular a breakthrough device designation for its BosSTENT, a cerebral venous stent designed to treat de...